Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impo...
FDA Device Recall #Z-0488-2021 — Class II — October 23, 2020
Recall Summary
| Recall Number | Z-0488-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 23, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Coloplast Manufacturing US, LLC |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 8,962 units |
Product Description
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Reason for Recall
Potential increased occurrence of pump fracture over the lifetime of the device.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP.
Lot / Code Information
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6781638, 6828422, 6949385, 6949386, 6949448, 6993344, 7007415, 7007444, 7012748, 7045698, 7108093, 7108094, 7108124, 7150024, 7150025, 7180872, 7263769, 7299901, 7299902, 7338036, 7348367, 7432372, 5584172, 6293585, 6563688, 6741635, 6759255, 6786417, 6993345, 7045699, 7289311, 7348368, 5585207, 5585208, 5860331, 5953311, 5953965, 5988741, 6046595, 6247928, 6337891, 6388057, 6401860, 6523188, 6526313, 6563689, 6565100, 6625342, 6663000, 6674052, 6741563, 6837792, 6886579, 6945905, 7007416, 7050967, 7108095, 7180873, 7263770, 5493076, 5585210, 5585231, 5585232, 5616472, 5637057, 5673512, 5748877, 5748878, 5852948, 5953313, 5953314, 6000539, 6046600, 6046671, 6121906, 6121950, 6125000, 6157438, 6203662, 6203698, 6247933, 6256295, 6257010, 6287830, 6293558, 6293559, 6337895, 6340896, 6401129, 6401862, 6408869, 6450609, 6461063, 6523192, 6523240, 6526318, 6565031, 6565139, 6565140, 6625344, 6625394, 6674055, 6674251, 6674292, 6713220, 6726455, 6741602, 6759257, 6781595, 6781596, 6781619, 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Other Recalls from Coloplast Manufacturing US, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0844-2025 | Class II | Folysil Silicone Foley Catheters, Device Refere... | Dec 2, 2024 |
| Z-0845-2025 | Class II | X-Flow prostatectomy catheter, Device Reference... | Dec 2, 2024 |
| Z-1463-2024 | Class II | Ureteral dilator, REF RBD014 | Mar 11, 2024 |
| Z-1360-2023 | Class II | Titan Pump Assembly, Catalog Number 5177701400;... | Mar 1, 2023 |
| Z-1366-2023 | Class II | Titan NB Scrotal Zero Ang 18cm, Catalog Number ... | Mar 1, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.